Ravindran Vinod, Rachapalli Satish, Choy Ernest H
Academic Department of Rheumatology, Sir Alfred Baring Garrod Clinical Trials Unit, Weston Education Centre, King's College London, London, UK.
Rheumatology (Oxford). 2009 Jul;48(7):807-11. doi: 10.1093/rheumatology/kep096. Epub 2009 May 15.
Several randomized controlled trials (RCTs) and meta-analyses have confirmed clinical efficacy of glucocorticoids in RA. Concerns regarding safety associated with medium- to long-term use in RA have limited their use in clinical practice. In this meta-analysis, we assessed the toxicity related to medium- to long-term (defined as 1 year or longer) glucocorticoid therapy in RA.
MEDLINE, EMBASE and CINAHL databases were searched for RCTs of glucocorticoids in RA. RCTs fulfilling the following criteria were included: double-blinded, placebo-controlled, lasted 1 year or longer, used prednisolone (or equivalent) and in English. Toxicity was assessed by number of the patients withdrawn for adverse events (AEs), and the numbers of serious adverse events (SAEs) and AEs. RCTs were compared by meta-analysis using odd ratios (OR) with 95% CIs.
Six RCTs with total of 689 patients met the inclusion criteria. All RCTs lasted >or=2 years. All studies allowed concomitant use of NSAIDs and DMARDs. Toxicity of glucocorticoid therapy based on number of patients withdrawn was limited (OR = 1.09; 95% CI 0.52, 2.25). Using number of AEs per patient-year (OR = 1.19; 95% CI 0.91, 1.57) and SAEs (OR = 1.06; 95% CI 0.67, 1.67) produced similar results. Efficacy/toxicity ratio was good for glucocorticoid therapy (number needed to harm/number needed to treat = 0.25).
Medium- to long-term glucocorticoid therapy in RA is associated with limited toxicity compared to placebo.
多项随机对照试验（RCT）和荟萃分析已证实糖皮质激素在类风湿关节炎（RA）中的临床疗效。对RA中长期使用糖皮质激素相关安全性的担忧限制了其在临床实践中的应用。在本荟萃分析中，我们评估了RA中长期（定义为1年或更长时间）糖皮质激素治疗的毒性。
检索MEDLINE、EMBASE和CINAHL数据库中关于糖皮质激素治疗RA的RCT。纳入符合以下标准的RCT：双盲、安慰剂对照、持续1年或更长时间、使用泼尼松龙（或等效药物）且为英文发表。通过因不良事件（AE）退出研究的患者数量、严重不良事件（SAE）数量和AE数量评估毒性。使用比值比（OR）及95%置信区间（CI）通过荟萃分析比较RCT。
6项RCT共689例患者符合纳入标准。所有RCT持续时间≥2年。所有研究均允许同时使用非甾体抗炎药（NSAID）和改善病情抗风湿药（DMARD）。基于退出患者数量的糖皮质激素治疗毒性有限（OR = 1.09；95%CI 0.52，2.25）。以患者每年AE数量（OR = 1.19；95%CI 0.91，1.57）和SAE数量（OR = 1.06；95%CI 0.67，1.67）计算得出类似结果。糖皮质激素治疗的疗效/毒性比良好（伤害所需人数/治疗所需人数 = 0.25）。
与安慰剂相比，RA中长期糖皮质激素治疗的毒性有限。
